Evidence map›Paper›PMID 32063088›Full record

ArticlemAbs

10

S Tourdot, A Abdolzade-Bavil, J Bessa, P Broët, A Fogdell-Hahn, M Giorgi, V Jawa, K Kuranda, N Legrand, S Pattijn and 8 more

Open access · goldAbstract readConference Proceedings
In one paragraph

Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.7field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Untoward immune effects of modern medication.Journal of biomedical research · 2023
    Article
  3. Article
  4. Review
  5. Article
  6. Public Health Impact of Using Biosimilars, Is Automated Follow up Relevant?International journal of environmental research and public health · 2020
    Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 15 institutions in 9 countries.

S TourdotBioMedicine Design, Pfizer Inc, Andover, MA, USA.
A Abdolzade-BavilLarge Molecule Bioanalytical Sciences, Pharma Research and Early Development (pRED), Roche Innovation Center Munich, Hoffmann-La Roche Ltd, Germany.
J BessaPharmaceutical Sciences, Pharma Research and Early Development (pRED), Roche Innovation Center Basel, Hoffmann-La Roche Ltd, Basel, Switzerland.
P BroëtFaculty of Medicine Paris-Saclay, Orsay, France.
A Fogdell-HahnDepartment of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.
M GiorgiCertara QSP, Certara UK Limited, UK.
V JawaPredictive and Clinical Immunogenicity, PPDM, Merck & Co, Kenilworth, NJ, USA.
K KurandaTranslational Department, Sparks Therapeutics, Philadelphia, PA, USA.
N LegrandGenOway, Lyon, France.
S PattijnImmunXperts SA, Gosselies, Belgium.
J A Pedras-VasconcelosOffice of Biotechnology Products, CDER, Food and Drug Administration, USA.
A RudyHEXAL AG, Holzkirchen, Germany.
P SalmikangasNDA Advisory Services Ltd, Surrey, UK.
D W ScottDepartment of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.
V SnoeckTranslational Biomarkers and Bioanalysis, UCB Biopharma SRL, Braine-l'Alleud, Belgium.
N SmithLonza, Slough, UK.
S SpindeldreherIntegrated Biologix GmbH, Basel, Switzerland.
D KramerSanofi R&D, Translational Medicine & Early Development, Sanofi, Frankfurt am Main, Germany.
Roche (Switzerland) · CHAdvisory Board Company (United States) · USGenoway (France) · FRHexal (Germany) · DEImmune Regulation (United Kingdom) · GBKarolinska Institutet · SELonza (United Kingdom) · GBMerck (Japan) · JPPfizer (United States) · USSanofi (Germany) · DESpark Therapeutics (United States) · USUCB Pharma (Belgium) · BEUniformed Services University of the Health Sciences · USUnited States Food and Drug Administration · USUniversité Paris-Saclay · FR

Funding

Induction of Tolerance to FVIII in HemophiliaR01HL126727 · NHLBI · HENRY M. JACKSON FDN FOR THE ADV MIL/MED · PI PRATT, KATHLEEN PALMER, SCOTT, DAVID WILLIAM · 2015 to 2022
$3.2M
NHLBI NIH HHS R01 HL126727
6 · The paper itself

Abstract

Therapeutic proteins and emerging gene and cell-based therapies are attractive therapeutic tools for addressing unmet medical needs or when earlier conventional treatment approaches failed. However, the development of an immune response directed against therapeutic agents is a significant concern as it occurs in a substantial number of cases across products and indications. The specific anti-drug antibodies that develop can lead to safety adverse events as well as inhibition of drug activity or accelerated clearance, both phenomena resulting in loss of treatment efficacy. The European Immunogenicity Platform (EIP) is a meeting place for experts and newcomers to the immunogenicity field, designed to stimulate discussion amongst scientists across industry and academia, encourage interactions with regulatory agencies and share knowledge and the state-of-the-art of immunogenicity sciences with the broader scientific community. Here we report on the main topics covered during the EIP 10th Open Symposium on Immunogenicity of Biopharmaceuticals held in Lisbon, 26-27 February 2019, and the 1-d training course on practical and regulatory aspects of immunogenicity held ahead of the conference. These main topics included immunogenicity testing, clinical relevance of immunogenicity, immunogenicity prediction, regulatory aspects, tolerance induction as a mean to mitigate immunogenicity and immunogenicity in the context of gene therapy.

Indexed as

AnimalsAntibodiesBiological ProductsEuropeHumansAntibodiesBiological ProductsADA testingclinical relevanceImmunogenicityrisk assessment

Identifiers

PMID32063088
PMCPMC7039638
OpenAlexW3005684746

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.